Balance 2.3% glucose, 1.75 mmol/L calcium, solution for peritoneal dialysis

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What balance is and what it is used for
2. What you need to know before using balance
3. How to use balance
4. Possible adverse effects
5. How to store balance
6. Contents of the pack and other information

1. What balance is and what it is used for

balance is used to clean the blood through the peritoneum in patients with end-stage chronic renal failure. This type of blood cleansing is known as peritoneal dialysis.

2. What you need to know before using balance

Do not usebalance 2.3% glucose, 1.75 mmol/l calcium

• if your blood potassium level is very low
• if your blood calcium level is very high
• if you have a metabolic disorder known as lactic acidosis

Peritoneal dialysis must not be started if you have:

• abdominal disorders such as

• wounds, or after surgical operation

• burns

• extensive inflammatory skin reactions

• peritonitis

• non-healed suppurating wounds

• umbilical, inguinal, or diaphragmatic hernias

• tumors in the abdomen or intestine

• inflammatory bowel diseases

• intestinal obstruction

• lung disease, especially pneumonia

• generalized blood infection caused by bacteria

• very high levels of fat in the blood

• accumulation in the blood of toxins originating from urine that cannot be removed by blood cleansing

• severe malnutrition and weight loss, especially if adequate protein nutrition is not possible.

Warnings and precautions

Consult your doctor immediately:

• in case of severe loss of electrolytes (salts) caused by vomiting and/or diarrhoea.
• in case of abnormal kidneys (polycystic kidneys)
• in case of peritonitis, recognizable because the peritoneal dialysis solution draining from your abdomen is cloudy and/or you have abdominal pain. Show the bag containing the drained solution to your doctor.
• in case of severe abdominal pain, abdominal distension, or vomiting. This may be a sign of encapsulating peritoneal sclerosis, a complication of peritoneal dialysis treatment that may be life-threatening.

Peritoneal dialysis may cause loss of proteins and water-soluble vitamins.

It is recommended that you follow an adequate diet or take dietary supplements to prevent nutritional deficiencies.

Your doctor should monitor your electrolyte (salt) balance, kidney function, body weight, and nutritional status.

Due to the high glucose concentration in balance 2.3% glucose, 1.75 mmol/l calcium, it should be used with caution and under the supervision of your doctor.

Use ofbalance with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Peritoneal dialysis may alter the effect of certain medicines, so your doctor may need to adjust the dose of some of them, especially the following:

• medicines for heart failure, such as digoxin.

Your doctor will check your blood potassium level and, if necessary, take appropriate measures.

• medicines affecting calcium levels, such as those containing calcium or vitamin D.

• medicines that increase urine excretion, such as diuretics.

• medicines taken orally and that lower blood sugar levels, or insulin. Blood sugar levels should be monitored regularly. Diabetic patients may require adjustment of their daily insulin dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. There are no adequate data on the use of balance in pregnant or breastfeeding women. If you are pregnant or breastfeeding, you should use balance only if your doctor considers it absolutely necessary.

Driving and use of machines

The influence of balance on the ability to drive or operate machinery is none or negligible.

3. How to use balance

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the method, duration and frequency of use, as well as the required volume of solution and the dwell time in the peritoneal cavity.

If you experience abdominal discomfort or pressure, your doctor may reduce the volume.

Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Adults: The usual dose is 2000 – 3000 ml of solution four times daily, depending on body weight and renal function.

The solution is drained after a dwell time of 2 to 10 hours.

• Children: The physician will determine the required volume of dialysis solution based on the child's tolerance, age, and body surface area.

The recommended initial dose is 600 – 800 ml/m² body surface area four times daily (up to 1000 ml/m² at night).

Automated Peritoneal Dialysis (APD)

For this type of dialysis, the sleep•safe or Safe•Lock system is used. Bag exchanges are automatically controlled by the cycler during the night.

• Adults: The usual prescription is 2000 ml (maximum 3000 ml) per exchange with 3–10 exchanges during the night over 8 to 10 hours, plus one or two daytime exchanges.

• Children: The volume per exchange should be 800–1000 ml/m² (up to 1400 ml/m²) of body surface area with 5–10 exchanges during the night.

Use balance only in the peritoneal cavity.

Use balance only if the solution is clear and the container is undamaged.

balance is supplied in a dual-chamber bag. Before using the solution, mix the contents of both chambers as described below.

Instructions for use:

stay•safe system for Continuous Ambulatory Peritoneal Dialysis (CAPD)

First, warm the solution bag to body temperature. This should be done using an appropriate bag warmer. The warming time depends on the volume of the bag and the type of bag warmer used (for a 2000 ml bag starting at 22°C, warming typically takes 120 minutes). Refer to your warmer’s instruction manual for more detailed information. Do not use microwave ovens to heat the solution due to the risk of local overheating. Bag exchange may be performed after the solution has been warmed.

1. Preparation of the solution

? Check the warmed solution bag (label, expiry date, clarity of solution, integrity of bag and overpouch, integrity of seals). ? Place the bag on a solid surface. ? Open the overpouch and remove the seal from the disinfection cap/closing cap. ? Wash your hands using an antimicrobial hand wash solution. ? Roll the bag, placed horizontally on the overpouch, from one side edge until the intermediate seal opens. The solutions from both chambers will mix automatically. ? Now roll the bag from the top edge until the lower triangular seal is fully opened. ? Check that all seals are completely open. ? Check that the solution is clear and the bag is leak-free.

1. Preparation for bag exchange

? Hang the solution bag on the upper hanger of the infusion stand. Unroll the tubes from the solution bag and place the DISC connector in the organizer. After unrolling the drainage bag tubes, hang the drainage bag on the lower hanger of the infusion stand. ? Place the catheter connector into one of the two ports of the organizer. ? Place the new disinfection cap/closing cap onto the remaining free port. ? Disinfect your hands and remove the protective cap from the DISC connector. ? Connect the catheter connector to the DISC connector.

1. Drainage flow

? Open the clamp on the extension set. Drainage flow begins.

? Position ?

1. Purge

? After drainage is complete, purge the drainage bag with fresh fluid (approximately 5 seconds).

? Position ??

1. Infusion flow

? Start the infusion flow by turning the rotary switch to the

? Position ???

1. Safety step

? Automatic closure of the catheter extension set with the PIN

? Position ????

1. Disconnection

? Remove the protective cap from the new disinfection cap/closing cap and screw it on securely. ? Unscrew the catheter connector from the DISC connector and screw it onto the new disinfection cap/closing cap.

1. Closing the DISC connector

? Close the DISC connector with the open end of the used protective cap, placing it into the other hole of the organizer.

1. Check the clarity and weight of the drained dialysate and, if the effluent is clear, discard it.

sleep•safe system for Automated Peritoneal Dialysis (APD)

For setup instructions for the sleep•safe system, refer to its instruction manual.

sleep•safe system 3000 ml

1. Preparation of the solution: see stay•safe system
2. Unroll the tube from the bag

3. Remove the protective cap

4. Place the connector into the free port on the cycler tray

5. The bag is ready for use with thesleep•safe equipment

sleep•safe system 5000 and 6000 ml

1. Preparation of the solution

? Check the solution bag (label, expiry date, clarity of solution, integrity of bag and overpouch, integrity of seals). ? Place the bag on a solid surface. ? Open the overpouch. ? Wash your hands using an antimicrobial hand wash solution. ? Unfold the intermediate seal and the bag connector. ? Roll the bag, placed horizontally on the overpouch, from the diagonal end toward the bag connector. The intermediate seal will open. ? Continue rolling until the seal of the small chamber is also opened. ? Check that all seals are completely open. ? Check that the solution is clear and the bag is leak-free.

1. – 5.: see sleep•safe 3000 ml system.

Safe•Lock system for Automated Peritoneal Dialysis (APD)

For setup instructions for the Safe•Lock system, refer to its instruction manual.

1. Preparation of the solution: see sleep•safe 5000 and 6000 ml system
2. Remove the protective cap from the connection line connector.
3. Connect the lines to the bag.
4. Break the internal lock by bending the line and the PIN more than 90º on both sides.
5. The bag is ready for use.

Bags are for single use only, and any unused solution must be discarded.

After appropriate training, balance can be used independently at home. Be sure to follow all steps learned during training and maintain proper hygiene when exchanging bags.

Always check the dialysate drainage for cloudiness. See section 2.

If you use morebalance than you should

If an excess of dialysis solution is infused into the peritoneal cavity, it may be drained out. If too many bags have been used, contact your doctor, as this may cause electrolyte and/or fluid imbalance.

If you forget to usebalance

Try to achieve the total prescribed volume for each 24-hour period to avoid potentially life-threatening consequences. Consult your doctor if you have any doubts.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You may experience the following adverse effects as a result of peritoneal dialysis treatment in general:

Very common (may affect more than 1 in 10 people)

• Inflammation of the peritoneum, indicated by cloudy dialysis fluid drained from your peritoneum, abdominal pain, fever, malaise, or, very rarely, blood infection.

Show the bag containing the drainage fluid to your doctor.

• Inflammation of the skin at the catheter exit site or along the length of the catheter, recognizable by redness, swelling, pain, exudation, or crusts.
• Abdominal wall hernia

Contact your doctor immediately if you experience any of these adverse effects.

Other adverse effects of the treatment include:

Common (may affect up to 1 in 10 people)

• Problems with inflow or outflow of dialysate
• Sensation of abdominal stretching or fullness
• Shoulder pain

Uncommon (may affect up to 1 in 100 people)

• Diarrhea
• Constipation

Very rare (may affect up to 1 in 10,000 people)

• Blood infection

Not known (frequency cannot be estimated from available data)

• Breathing difficulties
• Malaise
• Encapsulating peritoneal sclerosis, whose symptoms may include abdominal pain, abdominal distension, or vomiting

You may experience the following adverse effects when using balanc e:

Very common (may affect more than 1 in 10 people)

• Potassium deficiency

Common (may affect up to 1 in 10 people)

• Excess calcium if calcium intake is too high
• High blood sugar levels
• High blood fat levels
• Weight gain

Uncommon (may affect up to 1 in 100 people)

• Too low body fluid level, which may be recognized by rapid weight loss, decreased blood pressure, rapid pulse.
• Too high body fluid level, which may be recognized by fluid accumulation in tissues and lungs, high blood pressure, breathing difficulties.
• Dizziness

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pouch and carton after EXP. The expiry date is the last day of the month indicated.

Do not store at temperatures below 4°C.

The ready-to-use solution should be used immediately and within 24 hours of mixing.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of balance

• Active substances in 1 litre of ready-to-use solution are:

Calcium chloride dihydrate 0.2573 g
Sodium chloride 5.640 g
Solution of (S)-sodium lactate 7.85 g
(3.925 g (S)-sodium lactate)
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 25.0 g
(22.73 g glucose)

These quantities of active substances are equivalent to:
1.75 mmol/l calcium, 134 mmol/l sodium, 0.5 mmol/l magnesium, 101.5 mmol/l chloride, 35 mmol/l lactate and 126.1 mmol/l glucose.

The other components are water for injections, hydrochloric acid, sodium hydroxide and sodium bicarbonate.

Appearance of the product and contents of the pack

The solution is clear and colourless.

The theoretical osmolarity of the ready-to-use solution is 401 mOsm/l; the pH is approximately 7.0.

balance is available in dual-chamber bags. One chamber contains the alkaline sodium lactate solution and the other chamber contains the acidic glucose-electrolyte solution.

balance is available in the following administration systems and pack sizes:

stay•safe : 4 bags of 2000 ml 4 bags of 2500 ml 4 bags of 3000 ml

sleep•safe : 4 bags of 3000 ml 2 bags of 5000 ml 2 bags of 6000 ml

Safe•Lock: 2 bags of 5000 ml 2 bags of 6000 ml

Some pack sizes may not be marketed.

Marketing Authorization Holder:

Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany

Manufacturer:

Fresenius Medical Care Deutschland GmbH, Frankfurter Straße 6-8, 66606 St. Wendel, Germany

Local Representative:

Fresenius Medical Care España S.A.

C/ Ronda de Poniente, 8, ground floor, Parque Empresarial Euronova,

28760 Tres Cantos (Madrid)

Spain

This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

See end of this multilingual leaflet.

Date of the latest revision of this leaflet: 02/2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

CZ	balance 2.3% glucose, 1.75 mmol/l calcium solution for peritoneal dialysis
DE, AT, LU	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
DK	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
EE	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
EL, CY	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
ES	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
FI	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
FR	Continuous Ambulatory Peritoneal Dialysis 4, solution for peritoneal dialysis
HR	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
HU	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
IT	equibalance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
LT	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
LV	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
NL, BE	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
NO	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
PL	balance 2.3% glucose and 1.75 mmol/l calcium, solution for peritoneal dialysis
PT	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
RO	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
SE	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
SI	balance 23 mg/ml glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
SK	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis
UK(XI)	balance 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis